The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Ramona Hicks - One of the best experts on this subject based on the ideXlab platform.
-
pre clinical traumatic brain injury Common Data Elements toward a Common language across laboratories
Journal of Neurotrauma, 2015Co-Authors: Douglas H Smith, Ramona Hicks, Victoria E Johnson, Debra A Bergstrom, Diana M Cummings, Linda Noble, David A Hovda, Michael J Whalen, Stephen T Ahlers, Michelle C LaplacaAbstract:Abstract Traumatic brain injury (TBI) is a major public health issue exacting a substantial personal and economic burden globally. With the advent of “big Data” approaches to understanding complex systems, there is the potential to greatly accelerate knowledge about mechanisms of injury and how to detect and modify them to improve patient outcomes. High quality, well-defined Data are critical to the success of bioinformatics platforms, and a Data dictionary of “Common Data Elements” (CDEs), as well as “unique Data Elements” has been created for clinical TBI research. There is no Data dictionary, however, for preclinical TBI research despite similar opportunities to accelerate knowledge. To address this gap, a committee of experts was tasked with creating a defined set of Data Elements to further collaboration across laboratories and enable the merging of Data for meta-analysis. The CDEs were subdivided into a Core module for Data Elements relevant to most, if not all, studies, and Injury-Model-Specific mo...
-
progress in developing Common Data Elements for traumatic brain injury research version two the end of the beginning
Journal of Neurotrauma, 2013Co-Authors: Ramona Hicks, Alex B Valadka, Geoffrey T Manley, Joseph T Giacino, Cynthia Harrisonfelix, Elisabeth A WildeAbstract:Abstract To accelerate Data sharing and research on traumatic brain injury (TBI), several federal agencies have been collaborating to support the development and implementation of Common Data Elements (CDEs). The first recommendations for CDEs were made in 2010, and were well suited for hospital-based studies of acute TBI in adults. To broaden the utility of the TBI CDEs, experts were asked to update the recommendations to make them relevant to all ages, levels of injury severity, and phases of recovery. The second version of the TBI CDEs (v.2) was organized around four major study types: 1) epidemiological research; 2) studies on acute, hospitalized patients; 3) studies of the rehabilitation for moderate/severe TBI; and 4) mild TBI/concussion research. Given the heterogeneity of TBI, only a small set of core CDEs were found to be relevant across all study types. However, within groups, a much larger set of highly relevant CDEs were identified, and these were called basic CDEs. In addition, an expanded nu...
-
Common Data Elements for research on traumatic brain injury pediatric considerations
Journal of Neurotrauma, 2012Co-Authors: Cate A Miller, Joanne Odenkirchen, Annchristine Duhaime, Ramona HicksAbstract:Traumatic brain injury (TBI) is a significant global health problem, with a notably high incidence in children and adolescents. Despite the prevalence of TBI and the disabilities that often follow, research on which to base effective treatment is limited by several challenges, including but not limited to the complexity and heterogeneity of TBI. Even when rigorous methods are employed, the utility of the research may be limited by difficulties in comparing findings across studies resulting from the use of different measures to assess similar TBI study variables. Standardization of definitions and Data Elements is an important step toward accelerating the process of Data sharing that will ultimately lead to a stronger evidence base for treatment advances. To address this need, recommendations for Common Data Elements (CDEs) for research on TBI were developed through a 2009 national initiative. To ensure that the TBI CDE recommendations are relevant to pediatric populations, the National Institute on Disability and Rehabilitation Research (NIDRR) and the National Institute of Neurological Disorders and Stroke (NINDS) called for a review of the original recommendations. Following the process used for the original initiative, multidisciplinary work groups composed of pediatric TBI experts were formed (Demographics and Clinical Assessment; Biomarkers; Neuroimaging; and Outcomes Assessment). Recommendations for modifications and additions to the original CDEs were developed by the work groups, vetted at a 2010 workshop and further refined in preparation for publication. The pediatric considerations for TBI CDEs are described in a series of articles in this journal. This article describes the efforts leading to this pediatric CDE initiative and the CDE review and development process. It concludes with general recommendations for future iterations of the CDE initiative.
-
advancing integrated research in psychological health and traumatic brain injury Common Data Elements
Archives of Physical Medicine and Rehabilitation, 2010Co-Authors: Veronica Thurmond, Ramona Hicks, Theresa Gleason, Cate A Miller, Nicholas S Szuflita, Jean Langlois A Orman, Karen SchwabAbstract:In civilian, military, and veteran populations, there is increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders and the need to better understand the relationships by integrating research for these topics. The use of different measures to assess similar study variables and/or assess outcomes may limit important advances in PH and TBI research. Without a set of Common Data Elements (CDEs; to include variable definitions and recommended measures for the purpose of this discussion), comparison of findings across studies is challenging. The federal agencies involved in PH and TBI research, the National Institute of Neurological Disorders and Stroke, Department of Veterans Affairs, National Institute on Disability and Rehabilitation Research, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, and Defense and Veterans Brain Injury Center, therefore cosponsored a scientific initiative to develop CDEs for PH and TBI research. Scientific experts were invited to participate in 1 of 8 working groups to develop recommendations for specific topic-driven CDEs. Draft recommendations were presented and discussed in the workshop "Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements (CDE)" held on March 23-24, 2009, in Silver Spring, MD. The overall process leading to the workshop and subsequent recommendations by the working groups are presented in this article. Topic-driven recommendations for CDEs are presented in individual reports in this edition.
-
Common Data Elements in radiologic imaging of traumatic brain injury
Archives of Physical Medicine and Rehabilitation, 2010Co-Authors: Annchristine Duhaime, Pratik Mukherjee, Ramona Hicks, Mark E Haacke, Alisa D Gean, Max Wintermark, David L Brody, Lawrence L Latour, Gerard RiedyAbstract:Radiologic brain imaging is the most useful means of visualizing and categorizing the location, nature, and degree of damage to the central nervous system sustained by patients with traumatic brain injury (TBI). In addition to determining acute patient management and prognosis, imaging is crucial for the characterization and classification of injuries for natural history studies and clinical trials. This article is the initial result of a workshop convened by multiple national health care agencies in March 2009 to begin to make recommendations for potential Data Elements dealing with specific radiologic features and definitions needed to characterize injuries, as well as specific techniques and parameters needed to optimize radiologic Data acquisition. The neuroimaging work group included professionals with expertise in basic imaging research and physics, clinical neuroradiology, neurosurgery, neurology, physiatry, psychiatry, TBI research, and research Database formation. This article outlines the rationale and overview of their specific recommendations. In addition, we review the contributions of various imaging modalities to the understanding of TBI and the general principles needed for Database flexibility and evolution over time to accommodate technical advances.
Michael J Bell - One of the best experts on this subject based on the ideXlab platform.
-
Common Data Elements critical assessment of harmonization between current multi center traumatic brain injury studies
Journal of Neurotrauma, 2020Co-Authors: Sacha Meeuws, Hester F Lingsma, Michael J Bell, John K Yue, Jilske A Huijben, Nandesh Nair, Geoffrey T Manley, Andrew I R MaasAbstract:Standardization and harmonization of Data collection in studies on traumatic brain injury (TBI) is of paramount importance for meta-analyses across studies. Nearly 10 years ago, the first set of Common Data Elements for TBI (TBI-CDEs v1) were introduced to achieve these goals. The TBI-CDEs version 2 were developed in 2012 to broaden the approach to all ages, injury severity, and phases of recovery. We aimed to quantify the degree of harmonization of these Data Elements in three large, prospective multi-center studies conducted within the International Initiative for TBI Research (InTBIR). Data variables of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI; adult and pediatric patients in Europe and Israel), Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI; adult and pediatric patients in the U.S.), and Approaches and Decisions in Acute Pediatric TBI (ADAPT; international study on severe pediatric TBI) studies were indexed and matched to the second version of the TBI CDEs. We focused on the CDE sub-categories of "Acute Hospitalized" (AH) and "Moderate/Severe TBI: Rehabilitation (Rehab). All "Core" and "Basic" level CDEs were considered. Closely related Elements were reduced to one variable to prevent over-representation. Categorical Elements and text Elements for the same variable were likewise merged to one element for analysis. Following reduction and merging of related Elements, 21 Core, 46 Basic AH, and 50 Basic Rehab Elements were deemed harmonizable across studies. Gaps in global applicability were identified for four of the TBI CDEs and many of the outcome instruments, which are only available in the English language. Agreements of Core and Basic study CDEs for the AH domain with the TBI CDEs were respectively 81% and 91% for CENTER-TBI, 76% and 93% for TRACK-TBI, and 85% in ADAPT for both domains. For the domain Rehab, agreement with Basic TBI CDEs was 84% for CENTER-TBI, 94% for TRACK-TBI, and 71% for ADAPT. Non-harmonization was largely caused by absence of the Elements in the studies. For Elements present, the compatibility of coding with TBI CDEs was 90-99%. The degree of harmonization was greatest between CENTER-TBI and TRACK-TBI with 81-87% overlap within the TBI CDE sub-categories. The high degree of harmonization of study variables among these studies demonstrates the importance and utility of Common Data Elements in TBI research. It also confirms the potential for future meta-analyses across these large studies, especially for CENTER TBI and TRACK TBI. The global applicability of the TBI CDEs needs to be improved for them to become a global standard for TBI research. CENTER-TBI, TRACK-TBI, and ADAPT, along with other studies within the InTBIR Initiative, provide a platform to inform further refinement and internationalization for the next version of the TBI CDEs.
-
pediatric traumatic brain injury in 2012 the year with new guidelines and Common Data Elements
Critical Care Clinics, 2013Co-Authors: Michael J Bell, Patrick M KochanekAbstract:Traumatic brain injury (TBI) remains the leading cause of death of children in the developing world. In 2012, several international efforts were completed to aid clinicians and researchers in advancing the field of pediatric TBI. The second edition of the Guidelines for the Medical Management of Traumatic Brain Injury in Infants, Children and Adolescents updated those published in 2003. This article highlights the processes involved in developing the Guidelines, contrasts the new guidelines with the previous edition, and delineates new research efforts needed to advance knowledge. The impact of Common Data Elements within these potential new research fields is reviewed.
-
Common Data Elements for pediatric traumatic brain injury recommendations from the biospecimens and biomarkers workgroup
Journal of Neurotrauma, 2012Co-Authors: Rachel P Berger, Sue R Beers, Linda Papa, Michael J BellAbstract:Abstract Biospecimens represent a critically important resource in pediatric brain injury research. Data from these specimens can be used to identify and classify injury, understand the molecular mechanisms underlying different types of brain injury, and ultimately identify therapeutic targets to tailor treatments for individual patient needs. To realize the full potential of biospecimens in pediatric traumatic brain injury (TBI), standardization and adoption of best practice guidelines are needed to ensure the quality and consistency of specimens. Multiple groups, including the National Cancer Institute (NCI), the International Society for Biological and Environmental Repositories (ISBER), and the Organisation for Economic Co-operation and Development (OECD), have previously published best practice guidelines for biospecimen resources. Recommendations have also been provided by the Biospecimens and Biomarkers Workgroup of the interagency TBI Common Data Elements (CDE) initiative. The recommendations from...
-
Common Data Elements for pediatric traumatic brain injury recommendations from the working group on demographics and clinical assessment
Journal of Neurotrauma, 2012Co-Authors: David P Adelson, Michael J Bell, Rachel P Berger, Jose A Pineda, Nicholas S Abend, Christopher C Giza, Gillian Hotz, Mark S WainwrightAbstract:The Common Data Elements (CDEs) initiative is a National Institutes of Health (NIH) interagency effort to standardize naming, definitions, and Data structure for clinical research variables. Comparisons of the results of clinical studies of neurological disorders have been hampered by variability in Data coding, definitions, and procedures for sample collection. The CDE project objective is to enable comparison of future clinical trials results in major neurological disorders, including traumatic brain injury (TBI), stroke, multiple sclerosis, and epilepsy. As part of this effort, recommendations for CDEs for research on TBI were developed through a 2009 multi-agency initiative. Following the initial recommendations of the Working Group on Demographics and Clinical Assessment, a separate workgroup developed recommendations on the coding of clinical and demographic variables specific to pediatric TBI studies for subjects younger than 18 years. This article summarizes the selection of measures by the Pediatric TBI Demographics and Clinical Assessment Working Group. The variables are grouped into modules which are grouped into categories. For consistency with other CDE working groups, each variable was classified by priority (core, supplemental, and emerging). Templates were produced to summarize coding formats, guide selection of Data points, and provide procedural recommendations. This proposed standardization, together with the products of the other pediatric TBI working groups in imaging, biomarkers, and outcome assessment, will facilitate multi-center studies, comparison of results across studies, and high-quality meta-analyses of individual patient Data.
Annchristine Duhaime - One of the best experts on this subject based on the ideXlab platform.
-
Common Data Elements for neuroimaging of traumatic brain injury pediatric considerations
Journal of Neurotrauma, 2012Co-Authors: Annchristine Duhaime, Barbara A Holshouser, Jill V Hunter, Karen A TongAbstract:As part of the Traumatic Brain Injury Common Data Elements project, a large-scale effort to define Common Data Elements across a variety of domains, including neuroimaging, special considerations for pediatric patients were introduced. This article is an extension of that initial work, in which pediatric-specific pathoanatomical entities, technical considerations, interpretation paradigms, and safety considerations were reviewed. The goal of this review was to outline differences and specific information relevant to optimal performance and proper interpretation of neuroimaging in pediatric patients with traumatic brain injury. The long-range goal of this project is to facilitate Data sharing as well as to provide critical infrastructure for potential clinical trials in this major public health area.
-
Common Data Elements for research on traumatic brain injury pediatric considerations
Journal of Neurotrauma, 2012Co-Authors: Cate A Miller, Joanne Odenkirchen, Annchristine Duhaime, Ramona HicksAbstract:Traumatic brain injury (TBI) is a significant global health problem, with a notably high incidence in children and adolescents. Despite the prevalence of TBI and the disabilities that often follow, research on which to base effective treatment is limited by several challenges, including but not limited to the complexity and heterogeneity of TBI. Even when rigorous methods are employed, the utility of the research may be limited by difficulties in comparing findings across studies resulting from the use of different measures to assess similar TBI study variables. Standardization of definitions and Data Elements is an important step toward accelerating the process of Data sharing that will ultimately lead to a stronger evidence base for treatment advances. To address this need, recommendations for Common Data Elements (CDEs) for research on TBI were developed through a 2009 national initiative. To ensure that the TBI CDE recommendations are relevant to pediatric populations, the National Institute on Disability and Rehabilitation Research (NIDRR) and the National Institute of Neurological Disorders and Stroke (NINDS) called for a review of the original recommendations. Following the process used for the original initiative, multidisciplinary work groups composed of pediatric TBI experts were formed (Demographics and Clinical Assessment; Biomarkers; Neuroimaging; and Outcomes Assessment). Recommendations for modifications and additions to the original CDEs were developed by the work groups, vetted at a 2010 workshop and further refined in preparation for publication. The pediatric considerations for TBI CDEs are described in a series of articles in this journal. This article describes the efforts leading to this pediatric CDE initiative and the CDE review and development process. It concludes with general recommendations for future iterations of the CDE initiative.
-
Common Data Elements in radiologic imaging of traumatic brain injury
Archives of Physical Medicine and Rehabilitation, 2010Co-Authors: Annchristine Duhaime, Pratik Mukherjee, Ramona Hicks, Mark E Haacke, Alisa D Gean, Max Wintermark, David L Brody, Lawrence L Latour, Gerard RiedyAbstract:Radiologic brain imaging is the most useful means of visualizing and categorizing the location, nature, and degree of damage to the central nervous system sustained by patients with traumatic brain injury (TBI). In addition to determining acute patient management and prognosis, imaging is crucial for the characterization and classification of injuries for natural history studies and clinical trials. This article is the initial result of a workshop convened by multiple national health care agencies in March 2009 to begin to make recommendations for potential Data Elements dealing with specific radiologic features and definitions needed to characterize injuries, as well as specific techniques and parameters needed to optimize radiologic Data acquisition. The neuroimaging work group included professionals with expertise in basic imaging research and physics, clinical neuroradiology, neurosurgery, neurology, physiatry, psychiatry, TBI research, and research Database formation. This article outlines the rationale and overview of their specific recommendations. In addition, we review the contributions of various imaging modalities to the understanding of TBI and the general principles needed for Database flexibility and evolution over time to accommodate technical advances.
-
Common Data Elements in radiologic imaging of traumatic brain injury
Journal of Magnetic Resonance Imaging, 2010Co-Authors: Mark E Haacke, Pratik Mukherjee, Annchristine Duhaime, Alisa D Gean, Gerard Riedy, Max Wintermark, David L Brody, Thomas J Degraba, Timothy D Duncan, Elie ElovicAbstract:Traumatic brain injury (TBI) has a poorly understood pathology. Patients suffer from a variety of physical and cognitive effects that worsen as the type of trauma worsens. Some noninvasive insights into the pathophysiology of TBI are possible using magnetic resonance imaging (MRI), computed tomography (CT), and many other forms of imaging as well. A recent workshop was convened to evaluate the Common Data Elements (CDEs) that cut across the imaging field and given the charge to review the contributions of the various imaging modalities to TBI and to prepare an overview of the various clinical manifestations of TBI and their interpretation. Technical details regarding state-of-the-art protocols for both MRI and CT are also presented with the hope of guiding current and future research efforts as to what is possible in the field. Stress was also placed on the potential to create a Database of CDEs as a means to best record information from a given patient from the reading of the images.
Joanne Odenkirchen - One of the best experts on this subject based on the ideXlab platform.
-
ninds Common Data Elements for congenital muscular dystrophy clinical research a national institute for neurological disorders and stroke project
Journal of neuromuscular diseases, 2018Co-Authors: Michael W Lawlor, Joanne Odenkirchen, Sherita Alaihansen, Susan T Iannaccone, Katherine D Mathews, Francesco Muntoni, Robin FeldmanAbstract:Background A Congenital Muscular Dystrophy (CMD) Working Group (WG) consisting of international experts reviewed Common Data Elements (CDEs) previously developed for other neuromuscular diseases (NMDs) and made recommendations for all types of studies on CMD. Objectives To develop a comprehensive set of CDEs, Data definitions, case report forms and guidelines for use in CMD clinical research to facilitate interoperability of Data collection, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS). Methods One working group composed of ten experts reviewed existing NINDS CDEs and outcome measures, evaluated the need for new Elements, and provided recommendations for CMD clinical research. The recommendations were compiled, internally reviewed by the CMD working group, and posted online for external public comment. The CMD working group and the NIH CDE team reviewed the final version before release. Results The NINDS CMD CDEs and supporting documents are publicly available on the NINDS CDE website (https://www.CommonDataElements.ninds.nih.gov/CMD.aspx#tab=Data_Standards). Content areas include demographics, social status, health history, physical examination, diagnostic tests, and guidelines for a variety of specific outcomes and endpoints. The CMD CDE WG selected these documents from existing versions that were generated by other disease area working groups. Some documents were tailored to maximize their suitability for the CMD field. Conclusions Widespread use of CDEs can facilitate CMD clinical research and trial design, Data sharing and retrospective analyses. The CDEs that are most relevant to CMD research are like those generated for other NMDs, and CDE documents tailored to CMD are now available to the public. The existence of a single source for these documents facilitates their use in research studies and offers a clear mechanism for the discussion and update of the information as knowledge is gained.
-
improving the value of clinical research through the use of Common Data Elements
Clinical Trials, 2016Co-Authors: Jerry Sheehan, Steven Hirschfeld, Erin D Foster, Udi E Ghitza, Kerry Goetz, Joanna Karpinski, Lisa Lang, Richard P Moser, Joanne Odenkirchen, Dianne ReevesAbstract:The use of Common Data Elements can facilitate cross-study comparisons, Data aggregation, and meta-analyses; simplify training and operations; improve overall efficiency; promote interoperability between different systems; and improve the quality of Data collection. A Common Data Element is a combination of a precisely defined question (variable) paired with a specified set of responses to the question that is Common to multiple Datasets or used across different studies. Common Data Elements, especially when they conform to accepted standards, are identified by research communities from variable sets currently in use or are newly developed to address a designated Data need. There are no formal international specifications governing the construction or use of Common Data Elements. Consequently, Common Data Elements tend to be made available by research communities on an empiric basis. Some limitations of Common Data Elements are that there may still be differences across studies in the interpretation and implementation of the Common Data Elements, variable validity in different populations, and inhibition by some existing research practices and the use of legacy Data systems. Current National Institutes of Health efforts to support Common Data Element use are linked to the strengthening of National Institutes of Health Data Sharing policies and the investments in Data repositories. Initiatives include cross-domain and domain-specific resources, construction of a Common Data Element Portal, and establishment of trans-National Institutes of Health working groups to address technical and implementation topics. The National Institutes of Health is seeking to lower the barriers to Common Data Element use through greater awareness and encourage the culture change necessary for their uptake and use. As National Institutes of Health, other agencies, professional societies, patient registries, and advocacy groups continue efforts to develop and promote the responsible use of Common Data Elements, particularly if linked to accepted Data standards and terminologies, continued engagement with and feedback from the research community will remain important.
-
abstract wp332 updating the structure of stroke clinical research Data version 2 of the stroke Common Data Elements from the national institutes of health national institute of neurological disorders and stroke
Stroke, 2016Co-Authors: Joy Esterlitz, Sherita Alai, Muniza Sheikh, Jeffrey L Saver, Steven Warach, Thomas G Brott, Ralph L Sacco, Joanne OdenkirchenAbstract:Introduction: In order to increase the efficiency and effectiveness of neurovascular clinical research studies, increase Data quality, facilitate Data sharing, help educate new clinical investigators and reduce study start-up time, the National Institute of Neurological Disorders and Stroke (NINDS) convened a Working Group (WG) that developed Version 1.0 (published 2010) Stroke-specific Common Data Elements (CDEs). Since their initial publication, intervening advances in science and initial experience with the CDEs identified a need to update them and refine guidance on their deployment. Hypothesis/Objective: The NINDS has updated guidance on uniform Data structures for use in cerebrovascular research in epidemiology, clinical trials and imaging studies in order to advance the prevention, acute treatment and recovery from cerebrovascular disease. Methods: The NINDS convened experts in research and Data element design drawing strongly from investigators in the NIH StrokeNet and other NINDS clinical research projects. Results: Stroke CDE leadership developed a revised process for classifying Stroke CDEs among the four hierarchical categories of Core, Supplemental - Highly Recommended, Supplemental and Exploratory. Due to the heterogeneity of stroke conditions and study types, the classification of Supplemental - Highly Recommended was used for study type (clinical trial or observational), disease type (e.g., ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage) and disease phase (primary prevention, acute, recovery and secondary prevention). Conclusion: The second iteration of NINDS CDE recommendations for neurovascular disease is an important step towards more efficient study start-up time and improved Data sharing. The updated CDEs were released on the NINDS CDE website in May 2015. The information at this meeting will include examples of how the Stroke CDEs may be used by a research study, an explanation of the new CDE classifications, and examples of navigating and selecting CDEs from the NINDS CDE website. Support: This project was funded by HHSN271201200034C.
-
Common Data Elements for research on traumatic brain injury pediatric considerations
Journal of Neurotrauma, 2012Co-Authors: Cate A Miller, Joanne Odenkirchen, Annchristine Duhaime, Ramona HicksAbstract:Traumatic brain injury (TBI) is a significant global health problem, with a notably high incidence in children and adolescents. Despite the prevalence of TBI and the disabilities that often follow, research on which to base effective treatment is limited by several challenges, including but not limited to the complexity and heterogeneity of TBI. Even when rigorous methods are employed, the utility of the research may be limited by difficulties in comparing findings across studies resulting from the use of different measures to assess similar TBI study variables. Standardization of definitions and Data Elements is an important step toward accelerating the process of Data sharing that will ultimately lead to a stronger evidence base for treatment advances. To address this need, recommendations for Common Data Elements (CDEs) for research on TBI were developed through a 2009 national initiative. To ensure that the TBI CDE recommendations are relevant to pediatric populations, the National Institute on Disability and Rehabilitation Research (NIDRR) and the National Institute of Neurological Disorders and Stroke (NINDS) called for a review of the original recommendations. Following the process used for the original initiative, multidisciplinary work groups composed of pediatric TBI experts were formed (Demographics and Clinical Assessment; Biomarkers; Neuroimaging; and Outcomes Assessment). Recommendations for modifications and additions to the original CDEs were developed by the work groups, vetted at a 2010 workshop and further refined in preparation for publication. The pediatric considerations for TBI CDEs are described in a series of articles in this journal. This article describes the efforts leading to this pediatric CDE initiative and the CDE review and development process. It concludes with general recommendations for future iterations of the CDE initiative.
-
using the spinal cord injury Common Data Elements
Topics in Spinal Cord Injury Rehabilitation, 2012Co-Authors: F Bieringsorensen, Susan Charlifue, Michael J Devivo, Naomi Kleitman, Stacie T Grinnon, Joanne OdenkirchenAbstract:International Spinal Cord Injury (SCI) Data Sets include core, basic, and extended Data sets. To date, 13 Data sets have been published on the Web site of the International Spinal Cord Injury Society (ISCoS; www.iscos.org.uk), and several more are forthcoming. The Data sets are constituted of Data Elements, which may be appropriate to use in trials conducted to test novel therapeutic candidates including neuroprotective drugs, various cell types, and rehabilitative strategies and devices. The National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH), embarked on a Common Data Element (CDE) Project 5 years ago. The mission of the NINDS CDE Project is to develop Data standards for clinical research. The NINDS CDE team has since developed variable names and Database structures for the International SCI Data Sets (ie, the SCI CDEs; http://www.CommonDataElements.ninds.nih.gov/SCI.aspx). Dataset variable names and Database structure are exemplified with the International SCI Core Data Set and the International SCI Cardiovascular Function Basic Data Set. The consistency of the Data sets and the CDE format may improve the ability to transfer critical medical information electronically from one center to another. The goals of the SCI CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase Data quality, facilitate Data sharing, and help educate new clinical investigators. Pilot testing the SCI CDEs is an important step to ensure the SCI CDE effort achieves its goals.
Geoffrey T Manley - One of the best experts on this subject based on the ideXlab platform.
-
Common Data Elements critical assessment of harmonization between current multi center traumatic brain injury studies
Journal of Neurotrauma, 2020Co-Authors: Sacha Meeuws, Hester F Lingsma, Michael J Bell, John K Yue, Jilske A Huijben, Nandesh Nair, Geoffrey T Manley, Andrew I R MaasAbstract:Standardization and harmonization of Data collection in studies on traumatic brain injury (TBI) is of paramount importance for meta-analyses across studies. Nearly 10 years ago, the first set of Common Data Elements for TBI (TBI-CDEs v1) were introduced to achieve these goals. The TBI-CDEs version 2 were developed in 2012 to broaden the approach to all ages, injury severity, and phases of recovery. We aimed to quantify the degree of harmonization of these Data Elements in three large, prospective multi-center studies conducted within the International Initiative for TBI Research (InTBIR). Data variables of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI; adult and pediatric patients in Europe and Israel), Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI; adult and pediatric patients in the U.S.), and Approaches and Decisions in Acute Pediatric TBI (ADAPT; international study on severe pediatric TBI) studies were indexed and matched to the second version of the TBI CDEs. We focused on the CDE sub-categories of "Acute Hospitalized" (AH) and "Moderate/Severe TBI: Rehabilitation (Rehab). All "Core" and "Basic" level CDEs were considered. Closely related Elements were reduced to one variable to prevent over-representation. Categorical Elements and text Elements for the same variable were likewise merged to one element for analysis. Following reduction and merging of related Elements, 21 Core, 46 Basic AH, and 50 Basic Rehab Elements were deemed harmonizable across studies. Gaps in global applicability were identified for four of the TBI CDEs and many of the outcome instruments, which are only available in the English language. Agreements of Core and Basic study CDEs for the AH domain with the TBI CDEs were respectively 81% and 91% for CENTER-TBI, 76% and 93% for TRACK-TBI, and 85% in ADAPT for both domains. For the domain Rehab, agreement with Basic TBI CDEs was 84% for CENTER-TBI, 94% for TRACK-TBI, and 71% for ADAPT. Non-harmonization was largely caused by absence of the Elements in the studies. For Elements present, the compatibility of coding with TBI CDEs was 90-99%. The degree of harmonization was greatest between CENTER-TBI and TRACK-TBI with 81-87% overlap within the TBI CDE sub-categories. The high degree of harmonization of study variables among these studies demonstrates the importance and utility of Common Data Elements in TBI research. It also confirms the potential for future meta-analyses across these large studies, especially for CENTER TBI and TRACK TBI. The global applicability of the TBI CDEs needs to be improved for them to become a global standard for TBI research. CENTER-TBI, TRACK-TBI, and ADAPT, along with other studies within the InTBIR Initiative, provide a platform to inform further refinement and internationalization for the next version of the TBI CDEs.
-
validating multi dimensional outcome assessment using the traumatic brain injury Common Data Elements an analysis of the track tbi pilot study sample
Journal of Neurotrauma, 2017Co-Authors: Lindsay D Nelson, David O Okonkwo, Alex B Valadka, Geoffrey T Manley, Joseph T Giacino, Adam R Ferguson, Jana Ranson, Michael MccreaAbstract:The Glasgow Outcome Scale-Extended (GOSE) is often the primary outcome measure in clinical trials for traumatic brain injury (TBI). Although the GOSE's capture of global function outcome has several strengths, concerns have been raised about its limited ability to identify mild disability and failure to capture the full scope of problems patients exhibit after TBI. This analysis examined the convergence of disability ratings across a multidimensional set of outcome domains in the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot study. The study collected measures recommended by the TBI Common Data Elements (CDE) Workgroup. Patients presenting to 3 emergency departments with a TBI of any severity enrolled in TRACK-TBI prospectively after injury; outcome measures were collected at 3 and six months postinjury. Analyses examined frequency of impairment and overlap between impairment status across the CDE outcome domains of Global Level of Functioning (GOSE), Neuropsychological (cognitive) Impairment, Psychological Status, TBI Symptoms, and Quality of Life. GOSE score correlated in the expected direction with other outcomes (M Spearman's rho = .21 and .49 with neurocognitive and self-report outcomes, respectively). The subsample in the Upper Good Recovery (GOSE 8) category appeared quite healthy across most other outcomes, although 19.0% had impaired executive functioning (Trail Making Test Part B). A significant minority of participants in the Lower Good Recovery subgroup (GOSE 7) met criteria for impairment across numerous other outcome measures. The findings highlight the multidimensional nature of TBI recovery and the limitations of applying only a single outcome measure.
-
progress in developing Common Data Elements for traumatic brain injury research version two the end of the beginning
Journal of Neurotrauma, 2013Co-Authors: Ramona Hicks, Alex B Valadka, Geoffrey T Manley, Joseph T Giacino, Cynthia Harrisonfelix, Elisabeth A WildeAbstract:Abstract To accelerate Data sharing and research on traumatic brain injury (TBI), several federal agencies have been collaborating to support the development and implementation of Common Data Elements (CDEs). The first recommendations for CDEs were made in 2010, and were well suited for hospital-based studies of acute TBI in adults. To broaden the utility of the TBI CDEs, experts were asked to update the recommendations to make them relevant to all ages, levels of injury severity, and phases of recovery. The second version of the TBI CDEs (v.2) was organized around four major study types: 1) epidemiological research; 2) studies on acute, hospitalized patients; 3) studies of the rehabilitation for moderate/severe TBI; and 4) mild TBI/concussion research. Given the heterogeneity of TBI, only a small set of core CDEs were found to be relevant across all study types. However, within groups, a much larger set of highly relevant CDEs were identified, and these were called basic CDEs. In addition, an expanded nu...
-
Common Data Elements for research on traumatic brain injury and psychological health current status and future development
Archives of Physical Medicine and Rehabilitation, 2010Co-Authors: John Whyte, Jennifer J Vasterling, Geoffrey T ManleyAbstract:The National Institute of Neurologic Disorders and Stroke, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, National Institute on Disability and Rehabilitation Research, and Defense and Veterans Brain Injury Center jointly supported an effort to develop Common Data Elements (CDEs, ie, consensus-based content domains of importance and recommended ways to measure them) for research on traumatic brain injury and psychological health. The authors served as participants in this effort as well as editors of the resulting articles. This article describes the current status of this multiagency endeavor, the obstacles encountered, and possible directions for future development. Challenges that occurred within the working groups that developed the CDE recommendations and similarities and differences among the articles that describe those recommendations were reviewed. Across all of the working groups, there were challenges in striking a balance between specificity in recommendations to researchers and the need to tailor the selection of variables to specific study aims. The domains addressed by the different working groups varied in the research available to guide the selection of important content areas to be measured and the specific tools for measuring them. The working groups also addressed this challenge in somewhat different ways. The CDE effort must enhance consensus among researchers with similar interests while not stifling innovation and scientific rigor. This will require regular updating of the recommendations and may benefit from more standardized criteria for the selection of important content areas and measurement tools across domains.